Sex differences in the intensity of statin prescriptions at initiation in a primary care setting.

BACKGROUND: Current guidelines for the prevention and management of cardiovascular diseases (CVD) provide similar recommendations for the use of statins in both women and men. In this study, we assessed sex differences in the intensity of statin prescriptions at initiation and in the achievement of treatment targets, among individuals without and with CVD, in a primary care setting. METHODS: Electronic health record data from statin users were extracted from the PHARMO Data Network. Poisson regressions were used to investigate sex differences in statin intensity and in the achievement of treatment targets. Analyses were stratified by age group, disease status and/or CVD risk category. RESULTS: We included 82 714 individuals (46% women) aged 40-99 years old. In both sexes, the proportion of individuals with a dispensed prescription for high-intensity statin at initiation increased between 2011 and 2020. Women were less likely to be prescribed high-intensity statins as compared with men, both in the subgroups without a history of CVD (risk ratio (RR) 0.69 (95% CI: 0.63 to 0.75)) and with CVD (RR 0.77 (95% CI: 0.74 to 0.81)). Women were less likely than men to achieve target levels of low-density lipoprotein cholesterol following statin initiation in the subgroup without CVD (RR 0.98 (95% CI: 0.97 to 1.00)) and with a history of CVD (RR 0.94 (95% CI: 0.89 to 0.98)). CONCLUSION: Compared with men, women were less likely to be prescribed high-intensity statins at initiation and to achieve treatment targets, both in people without and with a history of CVD, and independent of differences in other individual and clinical characteristics.

The mediating role of health behaviors in the association between depression, anxiety and cancer incidence: an individual participant data meta-analysis.

BACKGROUND: Although behavioral mechanisms in the association among depression, anxiety, and cancer are plausible, few studies have empirically studied mediation by health behaviors. We aimed to examine the mediating role of several health behaviors in the associations among depression, anxiety, and the incidence of various cancer types (overall, breast, prostate, lung, colorectal, smoking-related, and alcohol-related cancers). METHODS: Two-stage individual participant data meta-analyses were performed based on 18 cohorts within the Psychosocial Factors and Cancer Incidence consortium that had a measure of depression or anxiety (N = 319 613, cancer incidence = 25 803). Health behaviors included smoking, physical inactivity, alcohol use, body mass index (BMI), sedentary behavior, and sleep duration and quality. In stage one, path-specific regression estimates were obtained in each cohort. In stage two, cohort-specific estimates were pooled using random-effects multivariate meta-analysis, and natural indirect effects (i.e. mediating effects) were calculated as hazard ratios (HRs). RESULTS: Smoking (HRs range 1.04-1.10) and physical inactivity (HRs range 1.01-1.02) significantly mediated the associations among depression, anxiety, and lung cancer. Smoking was also a mediator for smoking-related cancers (HRs range 1.03-1.06). There was mediation by health behaviors, especially smoking, physical inactivity, alcohol use, and a higher BMI, in the associations among depression, anxiety, and overall cancer or other types of cancer, but effects were small (HRs generally below 1.01). CONCLUSIONS: Smoking constitutes a mediating pathway linking depression and anxiety to lung cancer and smoking-related cancers. Our findings underline the importance of smoking cessation interventions for persons with depression or anxiety.

Practice visitations in primary care to improve performance of cardiovascular risk management.

BACKGROUND: Despite programmatic protocolized care and structured support, considerable variation is observed in completeness of registration and achieving targets of cardiovascular risk management between individual general practitioners in the Netherlands. AIM: To determine whether completeness of registration and achieved targets of cardiovascular risk factors improves with practice visitation. DESIGN & SETTING: Observational study utilizing the care groups' database (2016-2019) comparing changes in registration and achieved targets in non-visited practices and visited practices. METHOD: We compared completeness scores of registration and scores of targets achieved before visitation and 1 year after visitation. Data were analyzed on patient level and on general practitioners level. Separate analyses were performed among general practitioners who were ranked in the lower 25% of score distributions. RESULTS: We observed no clinically relevant improvements in completeness of registration and targets achieved in 2017, 2018 and 2019 that could be attributed to visitations in the previous year, both on individual patient level as on aggregated level per general practice.In practices ranked in the lower 25% of the distribution, improvements over time were clinically relevant and larger than the overall changes. Yet, these findings were irrespective of the number of practice visitations. CONCLUSION: Practice visitations in our setting did not seem to lead to improvements in practice performance, nor in completeness of registration of risk factors or in reaching predefined target goals for cardiovascular risk factors.

Patient characteristics and reasons for discontinuation in a cardiovascular risk management programme in The Netherlands.

BACKGROUND: Since 2010, an increasing number of patients have participated in a nurse-led integrated cardiovascular risk management programme in the Netherlands. Because it is important to understand which patients discontinue and why, when evaluating the effectiveness of the care programme, the aim was to identify the reasons for discontinuation. METHODS: Electronic health records of 3997 patients enrolled in a nurse-led integrated cardiovascular risk management programme that started on April 1st, 2010, were manually scrutinized for reasons for discontinuation between April 1st, 2010, and April 1st, 2018. In addition to death and moving to a diabetes care programme, we describe 7 different reasons why patients discontinued the programme and compared the patient characteristics of those who discontinued the programme without specific reasons with those who remained in the care programme for 8 years. RESULTS: Between April 1st, 2010, and April 1st, 2018, 1,190 participants (29.8%) discontinued the CVRM care programme, of whom 271 participants died (6.8%) and 195 were transferred to a diabetes care programme (4.9%). The remaining 724 patients (18.1%) participated 5 years before discontinuation. Of these, 67 (9.3%) had a previous cardiovascular event at the start of the programme. In 355 patients, a specific reason for discontinuation was not found. At baseline, these patients less frequently had a history of CVD than those who continued the programme for 8 years (1.7 vs. 22.6%), were younger (62 vs. 67 years), had less registered cardiovascular comorbidity (atrial fibrillation: 1.1 vs. 7.2%; congestive heart failure 0.3 vs. 1.2%; chronic kidney disease 0.0 vs. 4.5%), were more often smokers (13.0% vs. 4.3%) and took blood pressure- and lipid-lowering drugs twice as often. CONCLUSIONS: In our study we observed that participants who discontinued the nurse-led integrated CVRM care programme between 2010 and 2018 without specific reason or on request were younger, without previous CVD, had less cardiovascular comorbidity and were better adjusted to medication. Exploring the patients' reasons for discontinuation can contribute to an individualized approach to prevent or reduce discontinuation.

Sex Differences in the Primary Prevention of Cardiovascular Diseases in a Dutch Primary Care Setting.

Background: Sex differences in the primary prevention of cardiovascular diseases (CVD) have been shown, but the evidence is mixed and fragmented. In this study, we assessed sex differences in cardiovascular risk factors assessment, risk factor levels, treatment, and meeting of treatment targets, within a Dutch primary care setting. Methods: Data were obtained from individuals aged 40 to 70 years old, without prior CVD, registered during the entire year in 2018 at one of the 51 general practices participating in the Julius General Practitioner's Network (JGPN). History of CVD was defined based on the International Classification of Primary Care (ICPC). Linear and Poisson regressions were used to investigate sex differences in risk factor assessment, risk factor levels, treatment, and meeting of treatment targets. Results: We included 83,903 individuals (50% women). With the exception of glycated hemoglobin (HbA1c), all risk factors for CVD were more often measured in women than in men. Lipid measurements and body mass index values were higher in women, while blood pressure (BP) and HbA1c levels were higher in men, along with estimated glomerular filtration rate (eGFR) levels. Among individuals with elevated BP or cholesterol levels, no sex difference was observed in the prescription of antihypertensive medications (RR 1.00, 95% CI: 0.94-1.06) but women were less likely than men to receive lipid-lowering medications (RR 0.87, 95% CI: 0.79-0.95). Among treated individuals, women were more likely than men to meet adequate levels of blood pressure (RR 1.17, 95% CI: 1.09-1.25) and less likely to meet target levels of cholesterol (RR 0.90, 95% CI: 0.83-0.98). Conclusion: While women were more likely to have their CVD risk factors measured, they were less likely to be prescribed lipid-lowering medications and to meet target levels. When treated, men were less likely to achieve adequate blood pressure control.

Diagnostic yield of a proactive strategy for early detection of cardiovascular disease versus usual care in adults with type 2 diabetes or chronic obstructive pulmonary disease in primary care in the Netherlands (RED-CVD): a multicentre, pragmatic, cluster-randomised, controlled trial.

BACKGROUND: Progressive cardiovascular diseases (eg, heart failure, atrial fibrillation, and coronary artery disease) are often diagnosed late in high-risk individuals with common comorbidities that might mimic or mask symptoms, such as chronic obstructive pulmonary disease (COPD) and type 2 diabetes. We aimed to assess whether a proactive diagnostic strategy consisting of a symptom and risk factor questionnaire and low-cost and accessible tests could increase diagnosis of progressive cardiovascular diseases in patients with COPD or type 2 diabetes in primary care. METHODS: In this multicentre, pragmatic, cluster-randomised, controlled trial (RED-CVD), 25 primary care practices in the Netherlands were randomly assigned to usual care or a proactive diagnostic strategy conducted during routine consultations and consisting of a validated symptom questionnaire, followed by physical examination, N-terminal-pro-B-type natriuretic peptide measurement, and electrocardiography. We included adults (≥18 years) with type 2 diabetes, COPD, or both, who participated in a disease management programme. Patients with an established triple diagnosis of heart failure, atrial fibrillation, and coronary artery disease were excluded. In the case of abnormal findings, further work-up or treatment was done at the discretion of the general practitioner. The primary endpoint was the number of newly diagnosed cases of heart failure, atrial fibrillation, and coronary artery disease, adjudicated by an expert clinical outcome committee using international guidelines, at 1-year follow-up, in the intention-to-treat population. FINDINGS: Between Jan 31, 2019, and Oct 7, 2021, we randomly assigned 25 primary care centres: 11 to usual care and 14 to the intervention. We included patients between June 21, 2019, and Jan 31, 2022. Following exclusion of ineligible patients and those who did not give informed consent, 1216 participants were included: 624 (51%) in the intervention group and 592 (49%) in the usual care group. The mean age of participants was 68·4 years (SD 9·4), 482 (40%) participants were female, and 734 (60%) were male. During 1 year of follow-up, 50 (8%) of 624 participants in the intervention group and 18 (3%) of 592 in the control group were newly diagnosed with heart failure, atrial fibrillation, or coronary artery disease (adjusted odds ratio 2·97 [95% CI 1·66-5·33]). This trial is registered with the Netherlands Trial Registry, NTR7360, and was completed on Jan 31, 2023. INTERPRETATION: An easy-to-use, proactive, diagnostic strategy more than doubled the number of new diagnoses of heart failure, atrial fibrillation, and coronary artery disease in patients with type 2 diabetes or COPD in primary care compared with usual care. Although the effect on patient outcomes remains to be studied, our diagnostic strategy might contribute to improved early detection and timely initiation of treatment in individuals with cardiovascular disease. FUNDING: Dutch Heart Foundation.

Predicting adverse outcomes in adults with a community-acquired lower respiratory tract infection: a protocol for the development and validation of two prediction models for (i) all-cause hospitalisation and mortality and (ii) cardiovascular outcomes.

BACKGROUND: Community-acquired lower respiratory tract infections (LRTI) are common in primary care and patients at particular risk of adverse outcomes, e.g., hospitalisation and mortality, are challenging to identify. LRTIs are also linked to an increased incidence of cardiovascular diseases (CVD) following the initial infection, whereas concurrent CVD might negatively impact overall prognosis in LRTI patients. Accurate risk prediction of adverse outcomes in LRTI patients, while considering the interplay with CVD, can aid general practitioners (GP) in the clinical decision-making process, and may allow for early detection of deterioration. This paper therefore presents the design of the development and external validation of two models for predicting individual risk of all-cause hospitalisation or mortality (model 1) and short-term incidence of CVD (model 2) in adults presenting to primary care with LRTI. METHODS: Both models will be developed using linked routine electronic health records (EHR) data from Dutch primary and secondary care, and the mortality registry. Adults aged ≥ 40 years with a GP-diagnosis of LRTI between 2016 and 2019 are eligible for inclusion. Relevant patient demographics, medical history, medication use, presenting signs and symptoms, and vital and laboratory measurements will be considered as candidate predictors. Outcomes of interest include 30-day all-cause hospitalisation or mortality (model 1) and 90-day CVD (model 2). Multivariable elastic net regression techniques will be used for model development. During the modelling process, the incremental predictive value of CVD for hospitalisation or all-cause mortality (model 1) will also be assessed. The models will be validated through internal-external cross-validation and external validation in an equivalent cohort of primary care LRTI patients. DISCUSSION: Implementation of currently available prediction models for primary care LRTI patients is hampered by limited assessment of model performance. While considering the role of CVD in LRTI prognosis, we aim to develop and externally validate two models that predict clinically relevant outcomes to aid GPs in clinical decision-making. Challenges that we anticipate include the possibility of low event rates and common problems related to the use of EHR data, such as candidate predictor measurement and missingness, how best to retrieve information from free text fields, and potential misclassification of outcome events.

Cardiovascular risk reduction with integrated care: results of 8 years follow up.

BACKGROUND: Care groups organize integrated cardiovascular risk management programs in primary care for high risk patients. Results of long term cardiovascular risk management are scarce. The aim was to describe changes in low density lipoprotein cholesterol, systolic blood pressure and smoking between 2011 and 2018 in patients participating in an integrated program for cardiovascular risk management organized by a care group in the Netherlands. AIM: To explore whether long-term participation in an integrated cardiovascular risk management program could lead to the improvement of 3 important risk factors for cardiovascular disease. METHODS: A protocol was developed for delegated practice nurse activities. A multidisciplinary data registry was used for uniform registration. The care group organized annual education for general practitioners and practice nurses on cardiovascular topics and regular meetings for practice nurses only to discuss complex patient cases and implementation issues. From 2015 onwards, the care group started with practice visitations to discuss performance and support practices with organizing integrated care. RESULTS: In patients eligible for primary prevention as well as for secondary prevention similar trends were observed: lipid modifying and blood pressure lowering medication increased, mean low density lipoprotein cholesterol and mean systolic blood pressure decreased, patients on target for low density lipoprotein cholesterol and systolic blood pressure increased and the proportion of non-smokers with both low density lipoprotein cholesterol and systolic blood pressure on target increased. Improved registration between 2011 and 2013 was partly responsible for the sharp increase of patients on target for low density lipoprotein cholesterol and systolic blood pressure. CONCLUSION: In patients participating in an integrated cardiovascular risk management program, we saw annual improvements in 3 important cardiovascular risk factors between 2011 and 2018.

Evaluation of SGLT-2 inhibitor treatment in type 2 diabetes patients with very high cardiovascular risk.

AIMS: To evaluate whether the prescription of SGLT2-inhibitors in primary care patients with type 2 diabetes (T2DM) and a very high risk was according to the newest updated Dutch general practitioners' practice guidelines on T2DM. METHODS: This observational study with routine care data was conducted in a primary care setting in the Netherlands. The very high-risk population size was identified and analyzed via descriptive statistics. In this high-risk group the percentage of patients treated with SGLT2-inhibitors was assessed. RESULTS: Of the 1492 T2DM patients managed in primary care, 475 (31.8%) were classified as very high-risk based on (a history of) ischemic cardiovascular disease, chronic kidney disease, and/or heart failure. Of the very high-risk patients, 49 (10.3%) received SGLT2-inhibitors conform the guidelines. Of the remaining 426 high-risk patients 334 (70.3%) had no contraindication (eGFR <30 ml/min/1.73 m2 or HbA1c <53 mmol/mol) for initiating SGLT2-i prescription according to the guidelines. None of these patients received an GLP-1 agonist as alternative. CONCLUSIONS: The vast majority of very high-risk type 2 diabetes patients were not prescribed SGLT2-I. There is substantial room for improvement in the management of these critical T2DM patients because most of them had no contraindications for initiating SGLT2-I prescription.

Stepwise treatment of uncontrolled HyperTensioN (Stepwise-HTN): Study design of a cluster randomised controlled trial in primary care.

BACKGROUND: Uncontrolled hypertension is a major health problem, and a key risk factor for cardiovascular disease. Most patients are detected and managed in primary care, but approximately 50% remains uncontrolled. Our aim is to assess whether a guided stepwise work-up management strategy for patients with uncontrolled hypertension in primary care would result in better blood pressure control in these patients compared to usual care. METHODS: A cluster randomised controlled trial aiming at randomizing 40 general practices to either "a protocolised stepwise work-up" or to "usual care". Uncontrolled hypertension is defined as an office blood pressure (BP) >140/90 mmHg while being prescribed three or more antihypertensive drugs simultaneously from different therapeutic classes for three or more months in an adequate dose. In the intervention arm, patients with uncontrolled hypertension will receive the stepwise approach, consisting of (i) excluding a white coat effect, (ii) re-evaluation of lifestyle, (iii) re-evaluation of drug adherence, (iv) optimalisation of antihypertensive treatment and (v) referral if the office BP is still >140/90 mmHg. The control group receives usual care in a regular program for cardiovascular risk management. The primary outcome is the absolute difference in the mean 24-h systolic BP between intervention and control arm after 8 months. Secondary outcomes include differences in the percentage of patients achieving a controlled BP, and time to reach a controlled BP. CONCLUSION: If stepwise treatment of uncontrolled hypertension is proven effective, the strategy could be implemented by blending the approach to the cardiovascular risk management already applied in general practice. Trial registration NTR7304, https://www.trialregister.nl/trial/7099.

Health economic evaluation of nation-wide screening programmes for atrial fibrillation in the Netherlands.

AIMS: Screening for atrial fibrillation (AF) is recommended by the European Society of Cardiology guidelines to prevent strokes. Cost-effectiveness analyses of different screening programmes for AF are difficult to compare because of varying settings and models used. We compared the impact and cost-effectiveness of various AF screening programmes in the Netherlands. METHODS AND RESULTS: The base case economic analysis was conducted from the societal perspective. Health effects and costs were analysed using a Markov model. The main model inputs were derived from the ARISTOTLE, RE-LY, and ROCKET AF trials combined with Dutch observational data. Univariate, probabilistic sensitivity, and various scenario analyses were performed. The maximum number of newly detected AF patients in the Netherlands ranged from 4554 to 39 270, depending on the screening strategy used. Adequate treatment with anticoagulation would result in a maximum of >3000 strokes prevented using single-time point AF screening. Compared with no screening, screening 100 000 people provided a gain in QALYs ranging from 984 to 8727 and a mean cost difference ranging from -6650 000€ to 898 000€, depending on the screening strategy used. The probabilistic sensitivity analysis (PSA) demonstrated a 100% likelihood that screening all patients ≥75 years visiting the geriatric outpatient clinic was cost-saving. Four out of six strategies were cost-saving in ≥74% of the PSA simulations. Out of these, opportunistic screening of all patients ≥65 years visiting the GPs office had the highest impact on strokes prevented. CONCLUSION: Most single-time point AF screening strategies are cost-saving and have an important impact on stroke prevention.

Sex-specific and age-specific incidence of ischaemic heart disease, atrial fibrillation and heart failure in community patients with chronic obstructive pulmonary disease.

OBJECTIVE: To estimate the incidence of ischaemic heart disease, atrial fibrillation and heart failure in community patients with or without chronic obstructive pulmonary disease (COPD). METHODS: For this population-based study, we used primary care data of the Julius General Practitioners' Network. Eligible participants were aged 40-80 years old and contributed data between January 2014 and February 2019. Participants were divided into groups according to COPD status and were followed up for new ischaemic heart disease, atrial fibrillation and/or heart failure. Age-specific and sex-specific incidence and incidence rate ratios were calculated for patients with and without COPD. RESULTS: Mean follow-up was 3.9 years, 6223 patients were included in the COPD group, and 137 028 individuals in the background group without COPD. Incidence rates of all three heart diseases increased with age and were higher in males, independent of presence of COPD. Incidence rate ratios for patients with COPD, adjusted for age and sex, were 1.69 (95% CI 1.49 to 1.92) for ischaemic heart disease, 1.56 (95% CI 1.38 to 1.77) for atrial fibrillation and 2.96 (95% CI 2.58 to 3.40) for heart failure. CONCLUSION: The incidence of all major cardiovascular diseases is higher in patients with COPD, with the highest incidence rate ratio observed for heart failure.

Statins are associated with a large reduction in all-cause mortality in women from a cardiac outpatient population.

OBJECTIVES: Uncertainty about the benefit of (high-intensity) statins for women remains due to under-representation of women in primary prevention trials and scarcity of sex-stratified data. This study evaluates the sex-specific relation between statin treatment and survival and the additional benefit of high-intensity statins. METHODS: Electronic health record data from 47 801 patients (17 008 statin users and 30 793 non-users) without prior cardiovascular disease were extracted from thirteen Dutch outpatient cardiology clinics. Patients prescribed statins at baseline were propensity-score matched to those eligible for statin therapy (low-density lipoprotein >2.5 mmol/L) without a statin prescription. Statins were divided into low-intensity and high-intensity according to Dutch guidelines. Mortality data were obtained via linkage to the national mortality registry. Cox regression was used to evaluate the relationship between statin prescription and intensity and all-cause and cardiovascular mortality. RESULTS: Propensity score matching created a cohort of 8631 statin users and 8631 non-users. 35% of women and 28% of men received a low-intensity statin. The beneficial effect of statins on both all-cause and cardiovascular mortality was stronger in women (HR 0.66, 95% CI 0.58 to 0.74 and HR 0.55, 95% CI 0.39 to 0.71, respectively) than in men (HR 0.89, 95% CI 0.81 to 0.95 and HR 0.93, 95% CI 0.77 to 1.08, respectively). High-intensity statins conferred modest protection against all-cause mortality (HR 0.94, 95% CI 0.88 to 1.00) and cardiovascular mortality (HR 0.86, 95% CI 0.74 to 0.98) in both sexes. CONCLUSIONS: The protective effect of primary prevention statins was stronger in women than men for both all-cause and cardiovascular mortality. High-intensity statins conferred a modest additional benefit in both sexes. Statins seem to be effective regardless of treatment intensity, especially in women.

Blood pressure and cholesterol measurements in primary care: cross-sectional analyses in a dynamic cohort.

BACKGROUND: Guidelines on cardiovascular risk management (CVRM) recommend blood pressure (BP) and cholesterol measurements every 5 years in men aged ≥40 years and (post-menopausal) women aged ≥50 years. AIM: To evaluate CVRM guideline implementation. DESIGN & SETTING: Cross-sectional analyses in a dynamic cohort using primary care electronic health record (EHR) data from the Julius General Practitioners' Network (JGPN) (n = 388 929). METHOD: Trends (2008-2018) were assessed in the proportion of patients with at least one measurement (BP and cholesterol) every 1, 2, and 5 years, in those with:1. a history of cardiovascular disease (CVD) and diabetes mellitus (DM);2. a history of DM only;3. a history of CVD only;4. a cardiovascular risk assessment (CRA) indication based on other medical history, or;5. no CRA indication.Trends were evaluated over time using logistic regression mixed-model analyses. RESULTS: Trends in annual BP and cholesterol measurement increased for patients with a history of CVD from 37.0% to 48.4% (P<0.001) and 25.8% to 40.2% (P<0.001). In the 5-year window from 2014-2018, BP and cholesterol measurements were performed respectively in 78.5% and 74.1% of all men aged ≥40 years and 82.2% and 78.5% of all women aged ≥50 years. Least measured were patients without a CRA indication (men 60.2% and 62.4%; women 55.5% and 59.3%). CONCLUSION: The fairly high frequency of CVRM measurements available in the EHR of patients in primary care suggests an adequate implementation of the CVRM guideline. As nearly all individuals visit the GP at least once within a 5-year time window, improvement of CVRM remains possible, especially in those without a CRA indication.

European Society of Cardiology Quality Indicators for Cardiovascular Disease Prevention: developed by the Working Group for Cardiovascular Disease Prevention Quality Indicators in collaboration with the European Association for Preventive Cardiology of the European Society of Cardiology.

AIMS: To develop a set of quality indicators (QIs) for the evaluation of the care and outcomes for atherosclerotic cardiovascular disease (ASCVD) prevention. METHODS AND RESULTS: The Quality Indicator Committee of the European Society of Cardiology (ESC) formed the Working Group for Cardiovascular Disease Prevention Quality Indicators in collaboration with Task Force members of the 2021 ESC Guidelines on Cardiovascular Disease Prevention in Clinical Practice and the European Association of Preventive Cardiology (EAPC). We followed the ESC methodology for QI development, which involved (i) the identification of the key domains of care for ASCVD prevention by constructing a conceptual framework of care, (ii) the development of candidate QIs by conducting a systematic review of the literature, (iii) the selection of the final set of QIs using a modified Delphi method, and (iv) the evaluation of the feasibility of the developed QIs. In total, 17 main and 14 secondary QIs were selected across six domains of care for ASCVD prevention: (i) structural framework, (ii) risk assessment, (iii) care for people at risk for ASCVD, (iv) care for patients with established ASCVD, (v) patient education and experience, and (vi) outcomes. CONCLUSION: We present the 2021 ESC QIs for Cardiovascular Disease Prevention, which have been co-constructed with EAPC using the ESC methodology for QI development. These indicators are supported by evidence from the literature, underpinned by expert consensus and aligned with the 2021 ESC Guidelines on Cardiovascular Disease Prevention in Clinical Practice to offer a mechanism for the evaluation of ASCVD prevention care and outcomes.

Improving early diagnosis of cardiovascular disease in patients with type 2 diabetes and COPD: protocol of the RED-CVD cluster randomised diagnostic trial.

INTRODUCTION: The early stages of chronic progressive cardiovascular disease (CVD) generally cause non-specific symptoms that patients often do not spontaneously mention to their general practitioner, and are therefore easily missed. A proactive diagnostic strategy has the potential to uncover these frequently missed early stages, creating an opportunity for earlier intervention. This is of particular importance for chronic progressive CVDs with evidence-based therapies known to improve prognosis, such as ischaemic heart disease, atrial fibrillation and heart failure.Patients with type 2 diabetes or chronic obstructive pulmonary disease (COPD) are at particularly high risk of developing CVD. In the current study, we will demonstrate the feasibility and effectiveness of screening these high-risk patients with our early diagnosis strategy, using tools that are readily available in primary care, such as symptom questionnaires (to be filled out by the patients themselves), natriuretic peptide measurement and electrocardiography. METHODS AND ANALYSIS: The Reviving the Early Diagnosis-CVD trial is a multicentre, cluster randomised diagnostic trial performed in primary care practices across the Netherlands. We aim to include 1300 (2×650) patients who participate in a primary care disease management programme for COPD or type 2 diabetes. Practices will be randomised to the intervention arm (performing the early diagnosis strategy during the routine visits that are part of the disease management programmes) or the control arm (care as usual). The main outcome is the number of newly detected cases with CVDs in both arms, and the subsequent therapies they received. Secondary endpoints include quality of life, cost-effectiveness and the added diagnostic value of family and reproductive history questionnaires and three (novel) biomarkers (high-sensitive troponin-I, growth differentiation factor-15 and suppressor of tumourigenicity 2). Finally newly initiated treatments will be compared in both groups. ETHICS AND DISSEMINATION: The protocol was approved by the Medical Ethical Committee of the University Medical Center Utrecht, the Netherlands. Results are expected in 2022 and will be disseminated through international peer-reviewed publications. TRIAL REGISTRATION NUMBER: NTR7360.